First commercial use of Ra Medical System’s DABRA takes place in USA

27th June 2017

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The Heart Endovascular & Rhythm of Texas announced its latest collaboration with Ra Medical Systems to use the Destruction of Arteriosclerotic Blockages by laser Radiation Ablation (DABRA) system for the treatment of peripheral artery disease (PAD) in San Antonio, USA.

According to the City of San Antonio Metropolitan Health District, 14.2% of Bexar County adults have been diagnosed with (type 1 or type 2) diabetes, which is higher than the state and national average. People with diabetes have a high risk of serious health conditions such as diabetic amputations. In San Antonio, which has a higher-than average 14.2% prevalence of diabetes type 1 and 2, there has been a dramatic rise in the number of diabetic amputations.

The Heart Endovascular & Rhythm Institute of Texas is the first outpatient facility in Texas to commercially work with Ra Medical Systems to cross and treat arterial blockages via femoral artery access. It is also the first in the country to perform a procedure independent of the clinical trials for US Food and Drug Administration (FDA) clearance. This follows the California Heart & Vascular Clinic in El Centro, USA, which participated in a FDA clinical study and treated the first post-FDA clearance patient, associated with the study, in early June.

With treating arterial blockages, according to Charles Bailey, interventional cardiologist of Heart Endovascular & Rhythm of Texas, “There are very few devices that are available today that are effective for opening chronic total occlusions (CTOs). If you cannot get those vessels open, the only alternative is surgical, and unfortunately with surgical procedures, it runs the risk of infection,” says Bailey. “This laser and catheter is unlike any other device because of its design. The fact that you can open up a vessel that’s been closed for a long time and not have to place a stent in it and not have to operate on a patient, is phenomenal,” he adds.

The device is a catheter and excimer laser system for the treatment of complex and diffuse arterial blockages in the lower vessels. The single-use catheter is designed to produce a lumen while minimising trauma to the vasculature. It is a full catheter tip forward cutter, without the “dead-space” of fibre optic bundle catheters. The DABRA laser is designed to photochemically ablate arterial blockages, reducing calcium, thrombus and atheroma, minimising downstream debris. The portable laser weighs about 100 pounds.

Rhythm Endovascular & Heart Institute of Texas cath lab is working with Ra Medical Systems to be part of the next phase of clinical trials for coronary CTOs.